MedPath

Daclizumab

Generic Name
Daclizumab
Drug Type
Biotech
CAS Number
152923-56-3
Unique Ingredient Identifier
CUJ2MVI71Y

Overview

Humanized IgG1 Mab that binds to the human interleukin-2 receptor (anti-Tac or anti-CD25). Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody. On 22 April 2008, Roche Registration Limited chose to voluntarily withdraw the marketing authorization for their product Zenapax (daclizumab), as indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen like cyclosporine and corticosteroids in patients who are not hight immunized, for commercial reasons and confirmed that this decision was not related to any safety concerns associated with the use of Zenapax (daclizumab) . Regardless of the withdrawal of Zenapax, Biogen and Abbvie's Zinbryta (daclizumab), as indicated for the treatment of adult patients with relapsing forms of multiple sclerosis, was approved for use by the FDA in 2016 . Despite being approved for use, Zinbryta (daclizumab)'s complex pre-existing safety profile consisting of its restricted availability through a Risk Evaluation and Mitigation Strategy program and its black box warning for possible hepatic injury, autoimmune hepatitis, and other immune mediated disorders meant its therapeutic usage, adverse effects, and prescribing information was subject to continuous monitoring and updating. Although Zinbryta (daclizumab) was available for patients as needed until 30 April 2018, Biogen and Abbvie announced a voluntary withdrawal of their product Zinbryta (daclizumab) from the global market on 2 March 2018 . This withdrawal was concurrent to the European Medicines Agency announcement of a recall owing to 12 worldwide reports of serious inflammatory brain disorders associated with the use of Zinbryta (daclizumab) .

Indication

Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection

Associated Conditions

  • Relapsing Multiple Sclerosis (RMS)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2016/08/29
Phase 3
Terminated
2016/02/19
Phase 3
Completed
2015/10/15
Phase 4
Completed
2015/09/18
Phase 4
Completed
2010/07/29
Phase 4
Completed
2010/02/08
Phase 3
Completed
2009/03/10
Not Applicable
Completed
2009/02/19
Phase 1
Completed
2008/11/13
Phase 2
Withdrawn
2008/05/28
Phase 4
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ZINBRYTA
Biogen Canada Inc
02459639
Solution - Subcutaneous
150 MG / ML
N/A
ZENAPAX 5MG/ML
Hoffmann-La Roche Limited
02241473
Liquid - Intravenous
5 MG / ML
3/2/2000
ZINBRYTA
Biogen Canada Inc
02459620
Solution - Subcutaneous
150 MG / ML
3/30/2017

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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